MRI Markers of Cartilage Damage in Knee With Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by:
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00820430
First received: January 9, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 9, 2009
January 9, 2009
November 2006
May 2008   (final data collection date for primary outcome measure)
The primary study goals are to develop and evaluate MRI techniques that minimize systematic errors in measuring knee cartilage, and to assess the reproducibility of MRI techniques comparing normal and osteoarthritic knees across institutions. [ Time Frame: 4 sequental MRI evaluations of the target knee within a 4-week period ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
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MRI Markers of Cartilage Damage in Knee With Osteoarthritis
A Multi-Center Trial on MR Image Markers of Knee Articular Cartilage Damage in Osteoarthritis

The objectives of this study are: to identify and develop techniques to minimize precision errors in magnetic resonance imaging (MRI) evaluation of knee cartilage, and to determine if results from newly-identified MRI techniques in measuring cartilage changes and structure can be reproduced.

The development of a disease modifying osteoarthritis drugs (DMOADs) is currently limited by the inability to detect and monitor early cartilage damage that would be amenable to treatment. There is growing interest within the pharmaceutical and research community to use Magnetic Resonance Imaging (MRI) to identify biochemical and structural changes in the cartilage extra cellular matrix that occur early in the disease process. Although these techniques have been validated in small studies at single sites, multi-center evaluation of accuracy and precision, needed to apply these techniques to clinical trials of DMOADs, has not been performed. To address this need, the primary objective for this protocol is to identify and develop techniques to minimize systematic errors that decrease precision of MRI evaluation of knee cartilage, and to assess the reproducibility of the newly identified MRI techniques in measuring the cartilage morphometry and structure. Successful completion of this project may establish a multi-center imaging network in Pennsylvania for MRI evaluation of potential disease modifying osteoarthritis drugs (DMOADs) therapy.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

This multi-center trial comprises only facilities within Pennsylvania. Study participants for the normal cohorts will be recruited through print flyers. It is anticipated that the study participants with mild to moderate OA will be identified by the radiologists interpreting the knee x-rays.

Osteoarthritis, Knee
Other: Magnetic Resonance Imaging
Subjects will undergo 4 sequential MRI evaluations of the target knee within a 4 week period to calculate precision error (ICC) in determination of cartilage morphometry (cartilage volume, mean thickness, and surface area), cartilage collagen (regional cartilage T2), and cartilage proteoglycan (regional cartilage T1rho).
Other Names:
  • MRI
  • knee MRI
  • knee magnetic resonance imaging
  • Control--Non-Osteoporotic Knee
    Kellgren-Lawrence (KL) scale score of 0, Age: 18-35 years
    Intervention: Other: Magnetic Resonance Imaging
  • Minimal Osteoarthritis, Knee
    Kellgren-Lawrence (KL) scale score of 1 or 2, Age: Older than 18; no upper limit
    Intervention: Other: Magnetic Resonance Imaging
  • Moderate Osteoarthritis, Knee
    Kellgren-Lawrence (KL) scale score of 3, Age: Older than 18; no upper limit
    Intervention: Other: Magnetic Resonance Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants must be >18 years old;
  • Participants must have a KL score between 0 and 3;
  • Participants must have clearance to use protocol specified equipment: 3T MRI with parallel imaging capability and phased array knee coil (minimum 4 elements);
  • Participant had no change of treatment occur within the last 6 months;
  • Participants have no plans of changing to a different treatment within the next 3 months;
  • Participant must provide a study-specific signed informed consent form.

Exclusion Criteria:

  • Patients with contraindication to 3T MRI: Claustrophobia, Implanted metal or medical device that is not approved for MRI scanning at 3T, pregnancy, inability to tolerate relative immobility for 1 hour;
  • Patients with prior knee surgery or trauma of the knee;
  • Patients with KL score of 4.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00820430
ACRIN PA 4001, SAP #4100026182
Yes
Timothy J. Mosher, MD, Penn State Milton S. Hershey Medical Center
American College of Radiology Imaging Network
Pennsylvania Department of Health
Principal Investigator: Timothy J Mosher, MD Milton S. Hershey Medical Center
Study Chair: Ravinder Reddy, PhD University of Pennsylvania, MMRRCC
American College of Radiology Imaging Network
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP